Phase II Trial of Pentostatin and Targeted Busulfan

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to determine whether a regimen of pentostatin and busulfan (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression among 41 transplant patients meeting the inclusion criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Busulfan; Pentostatin; Rituximab

Criteria

Inclusion Criteria:

Recipients:

• Age: greater than 18 years of age, or younger with parental consent.

• HLA A, B, C, DRB1, DQB1, 10/10 or 9/10 allele sequence matched related donor or unrelated donor available

• Histologically confirmed diagnosis by pathologic review.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1, or Karnofsky performance status of greater than 70

• Organ function:

1. Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) >/= 50%

2. Cardiac: left ventricular ejection fraction >/= 50%

3. Renal: creatinine clearance (measured or calculated) equal or greater than 50 ml/min (at any time pentostatin is administered)

4. Hepatic: total bilirubin less than or equal to 2mg/dL, (Gilbert and other syndromes with increased indirect bilirubin should be allowed); serum transaminases less than two times the institutional upper limit of normal (< 2 x ULN).

Donors:

• Capable of receiving Granulocyte Colony-Stimulating Factor (G-CSF) and undergo apheresis

• Age >18

• Signed informed consent form in accordance with institutional or National Donor Marrow Program (NMDP) policies

Exclusion Criteria:

Recipients:

• Pregnant or lactating women

• HIV or seropositive, confirmed by nucleic acid test (NAT)

• Active central nervous system (CNS) malignancy

• Active infection

• Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care.

• Current use of metronidazole or acetaminophen; patients must discontinue use of these agents at least 7 days prior to the start of Busulfex administration

• Prior allogeneic HCT (patients who had received a prior autologous HCT will be allowed)

• Lack of a capable caregiver.

• Presence of any of the following comorbid conditions

1. History of recent myocardial infarction within 30 days

2. Congestive heart failure (NY class III, IV or if symptomatically uncontrolled)

3. Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency)

4. Untreated thoracic or abdominal aneurysm (6 cm or more)

5. History of any cerebrovascular accident including transient ischemic attacks within 30 days

6. Dementia

7. History of recent gastrointestinal bleeding (within 30 days)

8. Connective tissue/rheumatologic disorders

9. Hemiplegia/paraplegia

10. History of solid tumor excluding skin or cervical carcinoma after curative resection. Patients with other prior solid tumor (s) who are in remission for more than 5 years will be allowed on a case-by-case basis

Donors:

• Pregnant or lactating women

• HIV seropositive, confirmed by NAT

• Human T- lymphotropic virus (HTLV) I/II seropositive

• Hepatitis B or C seropositive

• Donors with uncontrolled bacterial, viral, fungal or parasitic infections.

• Donors with known hypersensitivity to recombinant human G-CSF or any E. coli-derived products.